Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT01386632
Brief Summary:
This will be a randomized masked placebo-controlled single-center study to evaluate the effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and Neck (SCCHN). Fifty subjects will be enrolled and randomly assigned on a 1:1 ratio to DCA or matching placebo given with standard of care treatment consisting of Cisplatin and radiation treatment.
Patients will receive DCA/placebo PO or per G-tube twice a day for 8 weeks. The first 6 patients of the total study population will represent a safety lead-in cohort. The results of the safety lead-in of DCA/placebo in combination with Cisplatin and radiation therapy will be evaluated after the 6th patient has completed 8 weeks of therapy. Recruitment of patients will be withheld during safety data analysis.
Detailed Description:
Doses for Cisplatin will be based on actual body weight taken on each day of Cisplatin therapy. DCA doses will be calculated at baseline according to actual body weight and will not change during the 8 weeks of therapy.
A careful description of the extent of the primary lesion and nodal spread will be recorded.
Dental Evaluation: Prior to treatment, patients will be evaluated by the dental service and a prophylactic cleaning/fluoride regimen instituted. A delay of at least 14 days from major surgery, including dental extractions, will be required prior to Day 1 treatment.
Airway Patency: Significant laryngeal edema has been described after the use of cisplatin containing regimens. Patients with laryngeal tumors should be considered for a prophylactic tracheostomy prior to the initiation of chemotherapy, if any possibility of airway compromise exists. Patients with laryngeal tumors experiencing respiratory stridor or compromise shortly after chemotherapy/radiotherapy administration should be rapidly evaluated for tracheostomy.
Alimentation: Significant stomatitis, mucositis and dysphagia are expected with these treatment regimens. Hospitalization may be required for symptomatic management. Pronounced weight loss is common, and adequate alimentation needs to be maintained. Early, if not pre-emptive, enteral tube feedings should be considered if difficulty is anticipated.
Compliance: The complexity of these treatment regimes and their attendant toxicity are such that compliance is of major concern. Patients expected to pose compliance problems should not be entered on this study. Patients will need to be seen at least weekly during therapy so that the toxicities can be monitored and treated.
Study:
NCT01386632
Study Brief:
Protocol Section:
NCT01386632